Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation

Sponsor

QuantuMDx Group Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05614011

Collaborator

EDP Biotech (Other), PathAI (Other), Bright Research Center (Other)

550

Enrollment

Locations

Arm

2.1

Anticipated Duration (Months)

183.3

Patients Per Site

85.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: RT-PCR Test Diagnostic Test: Real-time PCR Test	N/A

Detailed Description

The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.

The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan

Actual Study Start Date :

Nov 28, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects 18+ years of age A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.	Diagnostic Test: RT-PCR Test High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril. Diagnostic Test: Real-time PCR Test Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample. Other Names: Q-POC

Arm

Intervention/Treatment

Experimental: Subjects 18+ years of age

A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.

Diagnostic Test: RT-PCR Test

High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril.

Diagnostic Test: Real-time PCR Test

Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample.

Other Names:

Q-POC

Outcome Measures

Primary Outcome Measures

Positive Percent Agreement [3 months]
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Negative Percent Agreement [3 months]
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must be over the age of 18 years.
Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.
Participants must have capacity to give informed consent.

Exclusion Criteria:

Participant is under the age of 18 years.
Participant does not have symptoms of SARS-CoV-2 infection.
Participant lacks capacity to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bright Research Center	Miami	Florida	United States	33144
2	EDP Biotech	Knoxville	Tennessee	United States	37919
3	PathAI	Memphis	Tennessee	United States	38125

Sponsors and Collaborators

QuantuMDx Group Ltd
EDP Biotech
PathAI
Bright Research Center

Investigators

Study Director: Alice Neilson, QuantuMDx Group Ltd
Principal Investigator: Jason Liggett, PhD, EDP Biotech

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

QuantuMDx Group Ltd

ClinicalTrials.gov Identifier:

NCT05614011

Other Study ID Numbers:

QVTP-39

First Posted:

Nov 14, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 22, 2022